Clinical Trial Management System

Quality
Controlled Trial Management System (QCTMS) is an online Clinical Trial
Management System used by many small to midsize pharmaceutical, biotech and
medical device companies and CROs to plan, administer and control the essential
aspects of clinical trials.

Differently
to other CTMS solutions QCTMS has been developed by a clinical study team of
experienced project managers, clinical monitors and GCP auditors. The systematic
functionality is highly adaptable to sponsor-specific workflows and
terminologies. With QCTMS, clients do not need to modify their working
practices and compromise with inflexible, rigid functionality. The system is
able to manage trials of any complexity and support organizations of any size
and global reach. Containing all operational trial data, QCTMS allows consistent
and accurate information to be shared across the companies, partner and service
providers, thereby facilitating timely and informed decision making.

QCTMS
is available as an on-demand, software-as-a-service application enabling
customers to enjoy rapid and flexible deployment of our Clinical Trial
Management System solution without high upfront costs or need for extensive
training. Customers can also choose to implement QCTMS as an on-premise
solution and implement QCTMS it within their own operating environment.

QCTMS
provides an application framework in which we are able to converge our
integrated suite of clinical trial software applications. Designed to maximize
the benefit of natural trial process workflow, QCTMS enables users to plan,
design, collaborate and conduct their clinical trial programs from a
single point.

QCTMS
Modules

QCTMS PM – Supports
project management teams to keep oversight about large trials. It controls
budgets, investigator fees, milestones, timelines, enrollment summaries
and responsibilities. It gives automatic instructions and guidance to the
clinical monitoring teams who can report offline onsite information during
site visits or during their journeys to the system. All tools work with
standard software, no additional software needs to be installed on the
computers of QCTMS users.

QCTMS RM – Makes
your projects transparent for project teams. It analyses, tracks and
alerts key risk factors of all projects and trials through the countries
and sites involved, to details of the patients and their progress through
the trial. QCTMS also documents your Corrective and Preventive Actions
(CAPA) to avoid critical audit and/or inspection findings.

QCTMS TMF – The electronic Trial Master
File of QCTMS can be fully adjusted according to individual SOPs of the
sponsor or CRO. The centralized approach is an excellent solution for
multinational trials. Documents of each attending country can be filed and
maintained centrally from the first day until the end of the study.
Security, access control and movement control is continuously ensured.

QCTMS EDC – The
e-CRF module of QCTMS provides everything modern eCRFs can provide. The
advantages of receiving real time data, faster database logs and increased
data quality is commonly known. The reason for not using EDC is usually
the higher price compared to paper based CRFs. Using QCTMS EDC does not
increase project costs even for smaller projects. In connection with the
RM and PM modules of QCTMS projects can be run for 30% lower costs while achieving
a higher level of quality.

QCTMS IRT– The interactive response
technology of QCTMS allows centralized web based randomization and drug
assignment in an extremely user friendly way. We know that site personnel
are normally not very knowledgeable in sophisticated IT environments; this
fact alone allows us to develop a
simple, easy-to-use electronic tool which ensuring compliance by every
user.